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Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

Primary Purpose

Pruritus, Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Ondansetron (Zofran)
Dexamethasone (Decadron)
Spinal anesthesia
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pruritus

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology physical status 1 and 2
  • Scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria:

  • Patients with cardiac and psychological problems
  • Patients who take sedatives or narcotics
  • Patient who have allergy to study drugs

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ondansetron

Ondansetron+ dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Pruritus assessed through questionnaire

Secondary Outcome Measures

Post operative nausea and vomiting assessed through questionnaire

Full Information

First Posted
June 3, 2016
Last Updated
November 2, 2017
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02793843
Brief Title
Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section
Official Title
A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus. Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV). Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.
Detailed Description
A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Cesarean Section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Title
Ondansetron+ dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ondansetron (Zofran)
Intervention Description
Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (Decadron)
Intervention Description
Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia
Intervention Type
Other
Intervention Name(s)
Spinal anesthesia
Intervention Description
Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)
Primary Outcome Measure Information:
Title
Pruritus assessed through questionnaire
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Post operative nausea and vomiting assessed through questionnaire
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology physical status 1 and 2 Scheduled for elective c-section surgery under spinal anesthesia Exclusion Criteria: Patients with cardiac and psychological problems Patients who take sedatives or narcotics Patient who have allergy to study drugs
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

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